FDA.reportPublic FDA data

ELMED

Primary DI
00842180198630
Brand
ELMED
Company
ELMED INCORPORATED
Model
ST2425512OLY2
Catalog number
ST2425512OLY2
Device description
12mm, 5.5cm Olympus Style Thoracic Cannula
Published
2024-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GJCAssay, Sulfhemoglobin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GJCAssay, SulfhemoglobinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181173000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181173000ELMED Laparoscopic Instruments and AccessoriesElmed Incorporated2019-03-22GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842180198630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180198630008421801986308421801986300842180198630

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, reusableA single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is often provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. It is available in a variety of dimensions and/or designs. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags#

DUNS number
049290364
Device count
1
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198506056529ELMED INCORPORATEDSTT9920FSANSTT9920FSAN2026-10-16
00198506096075ELMED INCORPORATEDSTT9931FSANTSTT9931FSANT2026-10-16
00198506096082ELMED INCORPORATEDSTT9924FSANSTT9924FSAN2026-10-16
00198506096099ELMED INCORPORATEDST9932FSANTSTT9932FSANT2026-10-16
00198506095757ELMED INCORPORATEDST511740ST5117402026-10-09
00198506095764ELMED INCORPORATEDST7162700ST71627002026-10-09
00198506095771ELMED INCORPORATEDST233698ST2336982026-10-09
00198506095788ELMED INCORPORATEDST238248ST2382482026-10-09
00198506095795ELMED INCORPORATEDST365720ST3657202026-10-09
00198506095801ELMED INCORPORATEDST307060ST3070602026-10-09
00198506095818ELMED INCORPORATEDST307061ST3070612026-10-09
00198506095825ELMED INCORPORATEDST307062ST3070622026-10-09
00198506095832ELMED INCORPORATEDST307063ST3070632026-10-09
00198506095849ELMED INCORPORATEDST186403612ST1864036122026-10-09
00198506095856ELMED INCORPORATEDST1580095ST15800952026-10-09
00198506095870ELMED INCORPORATEDST33694-01ST33694-012026-10-09
00198506095887ELMED INCORPORATEDST7141014ST71410142026-10-09
00198506095894ELMED INCORPORATEDST7141015ST71410152026-10-09
00198506095900ELMED INCORPORATEDST7141016ST71410162026-10-09
00198506095917ELMED INCORPORATEDST7141017ST71410172026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429133MillenniumAvalign Technologies, Inc.GJC2026-09-04
00842180198562ELMEDELMED INCORPORATEDGJC2024-04-23
00842180198579ELMEDELMED INCORPORATEDGJC2024-04-23
00842180198623ELMEDELMED INCORPORATEDGJC2024-04-23
00842180175648ELMEDELMED INCORPORATEDGJC2023-08-08
00842180157699ELMEDELMED INCORPORATEDGJC2023-07-10
00842180167278ELMEDELMED INCORPORATEDGJC2023-04-17
00842180167285ELMEDELMED INCORPORATEDGJC2023-04-17
00842180167292ELMEDELMED INCORPORATEDGJC2023-04-17
00190776294892MillenniumAvalign Technologies, Inc.GJC2022-12-12
00190776296629MillenniumAvalign Technologies, Inc.GJC2022-12-12
00192896100831V.A.T.S. FOERSTER CLAMPSONTEC INSTRUMENTS, INC.GJC2020-02-24
04250480107614NASCHÖLLY FIBEROPTIC GmbHGJC2019-02-15
04042761010283OlympusOLYMPUS Winter & Ibe GmbHGJC2016-09-21
00385480420136STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480420143STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480420174STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480420181STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485623STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485586STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485616STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485630STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485647STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485661Stat ProfileNOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485678STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485685STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485838STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485845STAT PROFILENOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485852Stat ProfileNOVA BIOMEDICAL CORPORATIONGJC2016-09-20
00385480485876Stat ProfileNOVA BIOMEDICAL CORPORATIONGJC2016-09-20